Back to resultsA Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers
Primary Purpose
Congenital Bleeding Disorder, Haemophilia A, Haemophilia B
Status
Completed
Phase
Phase 1
Locations
United Kingdom
Study Type
Interventional
Intervention
activated recombinant human factor VII, long acting
placebo
activated recombinant human factor VII, long acting
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Bleeding Disorder
Eligibility Criteria
Inclusion Criteria:
- Caucasian origin
- Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive
- Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)
Exclusion Criteria:
- Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®)
- Previous participation in this trial, defined as randomised to receive trial product
- Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator
- Known history of atherosclerosis or thromboembolic events
- Overt bleeding, including from gastrointestinal tract
- Hepatitis B or C infection
- HIV infection
- Positive test for drugs of abuse
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Experimental
Arm Label
A
B
C
Arm Description
Outcomes
Primary Outcome Measures
Number of adverse events
Secondary Outcome Measures
Area under activity concentration-time curve from time zero to infinity
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00951873
Brief Title
A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers
Official Title
A Single-centre, Randomised, Placebo-controlled, Double-blind Single Dose, Dose Escalation Trial Investigating Safety, Pharmacokinetics and Local Tolerability of Ascending Subcutaneous Doses of Long Acting-rFVIIa in Healthy Male Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, local tolerability and pharmacokinetic profile (the determination of the concentration of the administered medication in blood over time) of long acting activated recombinant human factor VII when injected subcutaneously (under the skin).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Bleeding Disorder, Haemophilia A, Haemophilia B, Healthy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Title
B
Arm Type
Placebo Comparator
Arm Title
C
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII, long acting
Intervention Description
Single injection of long acting activated recombinant human factor VII subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Single injection of long acting activated recombinant human factor VII placebo subcutaneously (under the skin). Each treatment dose of 0,1 mg/kg, 0,3 mg/kg and 0,5 mg/kg is assessed for safety before escalating to next dose.
Intervention Type
Drug
Intervention Name(s)
activated recombinant human factor VII, long acting
Intervention Description
Single dose of 0,1 mg/kg long acting activated recombinant human factor VII injected intravenously (into a vein).
Primary Outcome Measure Information:
Title
Number of adverse events
Time Frame
assessed throughout the trial period from visit 1 to visit 5
Secondary Outcome Measure Information:
Title
Area under activity concentration-time curve from time zero to infinity
Time Frame
assessed up to 168 hours after trial product administration
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Caucasian origin
Body weight between 50 and 100 kg and a Body Mass Index (BMI) between 18.0 and 28.0 kg/m2 inclusive
Smoke less than 10 cigarettes/day or equivalent and willingness to abstain from smoking during the entire duration of Trial Product Administration (9 days)
Exclusion Criteria:
Known or suspected allergy to trial product or related products, such as activated recombinant human factor VII (NovoSeven®)
Previous participation in this trial, defined as randomised to receive trial product
Evidence of clinically relevant pathology or potential thromboembolic risk as judged by the Investigator
Known history of atherosclerosis or thromboembolic events
Overt bleeding, including from gastrointestinal tract
Hepatitis B or C infection
HIV infection
Positive test for drugs of abuse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
12. IPD Sharing Statement
Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk
Learn more about this trial
A Single Dose Trial Investigating Safety and Local Tolerability of Ascending Doses of Long Acting Activated Recombinant Human Factor VII in Healthy Male Volunteers
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